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Study Shows Ropinirole Is An Effective Treatment For Parkinson's Disease
Ropinirole Offers Long-term Control of Motor Symptoms and Delays Need for
Levodopa Therapy
Boston, MA, April 16, 1997 -- Patients with early Parkinson's disease can
achieve effective control of motor symptoms when treated with ropinirole
(Requip, SmithKline Beecham), according to a new twelve month study. The
study also showed that significantly more patients treated with ropinirole
did not require supplemental treatment with levodopa compared to
placebo-treated patients. Ropinirole is an important development in the
treatment of Parkinson's disease. Unlike currently available dopamine
agonists, ropinirole has demonstrated efficacy in placebo-controlled
clinical trials when used as early monotherapy and may offer a new
approach to treating Parkinson's disease. These results were presented
today at the 49th annual meeting of the American Academy of Neurology
(AAN) in Boston.
Parkinson's disease patients suffer from a deficiency of dopamine in the
brain. Levodopa, which is a precursor of dopamine, is administered as a
form of replacement therapy. Although this drug is very effective
initially, after long-term use many patients develop disabling side
effects which include dyskinesias (involuntary movements such as
twitching, nodding or jerking), neuropsychiatric problems (e.g.
hallucinations) and fluctuations of motor response.
Dopamine agonists are also administered to correct the dopamine deficiency
in Parkinson's disease patients and thereby reduce symptoms. These drugs
mimic the effects of dopamine by binding to and stimulating dopamine
receptors in the brain. A reduced level of dopamine at these receptors is
believed to cause the motor symptoms of Parkinson's disease. Ropinirole
is a second-generation, non-ergot dopamine agonist that selectively binds
to the D2 family of receptors. Clinical studies have shown the
effectiveness of ropinirole in improving the motor symptoms of Parkinson's
disease, either as early monotherapy or in the later stages as adjunctive
therapy with levodopa in patients experiencing motor fluctuations.
Currently available dopamine agonists are indicated for use only in
advanced Parkinson's disease.
The results presented today were from a continuation of an initial six
month, double blind, placebo-controlled clinical trial. In the initial
six month trial, which was presented at last year's AAN meeting, patients
treated with ropinirole showed significant improvement in motor function,
and significantly fewer of these patients required supplemental levodopa
therapy compared to the placebo patients.
Patients who satisfactorily completed the initial trial were eligible for
enrollment in the double blind, placebo-controlled, six month extension
study. A total of 147 patients elected to enter the extension study.
Investigators assessed the efficacy of ropinirole over the entire twelve
month period. A statistically significantly greater proportion of
patients in the ropinirole group (44 percent) received monotherapy for
twelve months without the need for levodopa, compared to the placebo group
(22.4 percent). In addition, fewer patients treated with ropinirole (19
percent) required additional symptomatic therapy with levodopa compared to
patients in the placebo group (45.6 percent) at the end of the twelve
month period. This difference was also statistically significant.
Parkinson's disease, which affects between 500,000 and 1,000,000
Americans, is a chronic and progressive neurological disorder that causes
uncontrollable tremors, rigidity of the muscles and other severe motor
impairments. Parkinson's disease results from the death of nerve cells in
a critical area of the brain called the substantia nigra. These nerve
cells normally produce dopamine, a chemical messenger that plays an
important role in motor control by transmitting signals between the
substantia nigra and another critical area of the brain called the
striatum. Dopamine depletion results in an impaired ability to initiate
and control movements.
Requip is currently under review at the U.S. Food and Drug Administration
(FDA) for treatment of Parkinson's disease, both as early monotherapy and
as adjunctive treatment with levodopa.
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